Detection of Breast Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC

Breast Cancer Screening Using DNA Methylation Changes in Circulated Tumor, PBMC and T-cells DNA.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03480659

Enrollment

165

Registered

2018-03-29

Start date

2018-06-01

Completion date

2021-09-01

Last updated

2023-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Breast Cancer Female

Brief summary

A central challenge in the fight against breast cancer is how to detect disease in a noninvasive manner before it is detectable by imaging methods. Although inroads have been made with more sensitive imaging techniques for earlier detection of breast cancer, these techniques are limited by the size of lesion that could be detected. Alternatively, several blood proteomic biomarkers have been proposed but none offer as of yet sufficient predictive power. Consequently, effective non-invasive tools as prognostic indicators and biomarkers of breast cancer are urgently needed. The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC and circulated tumor DNA in breast cancer patients.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

Healthy volunteers

Yes

Inclusion criteria

* Histological confirmed breast cancer subtypes (DCIS and invasive)

Exclusion criteria

* Pregnant women * Minors (subjects less than 18 years of age) * Prisoners * Patients with known infectious disease, such as human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B, C * Patients having other than one cancer * Subjects unable to consent for themselves

Design outcomes

Primary

Measure	Time frame	Description
DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of breast cancer	6 months to 1 year	We will develop the linear model and a threshold value differentiating breast cancer from control based on the 100 patient training set. The model will be provided to the researchers: Methylation score=CG1\b1+CG2\b2+ CG3\*b3 + e CG1 is the methylation value of the first CG b1 is the regression coefficient for the first CG and e equals the intercept. We will develop the regression coefficient and intercept as well as the DNA methylation values for each patient for each CG. We will first compute the polygenic methylation score for each patient. Then based on the computer threshold based on the training cohort will call the samples as breast cancer or not.

Countries

Kazakhstan

Outcome results